K202097 is an FDA 510(k) clearance for the Fundus Camera. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Huvitz Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on February 2, 2021, 188 days after receiving the submission on July 29, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K202097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2020 |
| Decision Date | February 02, 2021 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI - Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |